What Should We Know About Bioavailability and Bioequivalence?
Journal Title: Nature & Science - Year 2025, Vol 7, Issue 3
Abstract
Bioequivalence studies a crucial role in the development and approval of generic drugs, requiring input from multiple disciplines, including regulatory affairs, pharmacokinetics, and statistics. These studies assess whether the test (T) and reference (R) formulations exhibit similar bioavailability, ensuring therapeutic equivalence. Typically, they involve well-established study designs, such as parallel or crossover approaches, which help compare the pharmacokinetic parameters of both formulations. The bioanalytical methods used in these studies must be highly accurate, precise, selective, sensitive, and reproducible to generate reliable data. Peripheral blood, including plasma, serum, or whole blood, is the most commonly used biological matrix for evaluating a drug’s systemic availability. The collection and analysis of biological fluid samples allow for the quantification of the active drug ingredient, its active moiety, and, when necessary, its active metabolites. These measurements are essential for determining the pharmacokinetic properties of the drug and ensuring compliance with regulatory bioequivalence criteria, ultimately supporting safe and effective drug substitution.
Authors and Affiliations
Aytakin Mammadova, Oktay Aliyev, Narmin Taghiyeva
Keywords
Related Articles
- EP ID EP763723
- DOI 10.36719/2707-1146/54/30-34
- Views 19
- Downloads 0
COVİD-19: EPİDEMİOLOJİ XÜSUSİYYƏTLƏR TƏHLİLİ
There have been three fatal coronavirus-related pandemics in the twenty-first century: SARS (2002), MERS (2012), and COVID-19(2019). COVID19 first appeared in Wuhan, China, in December 2019 and quickly spread worldwide....
Parasitology ‒ As an Important Scientific Field of Medicine
Abstract Medical parasitology is the science that studies human parasites, diseases caused by them, and measures to combat these diseases. Medical parasitology is an important part of the science of parasitology (whic...
ENDOCRINOLOGY IN PREGNANCY AND OSTEOPAROSIS
Pregnancy defines a challenging period to the mother's bones because the building of the fetal skeleton requires a substantial transfer of calcium. This process is particularly intense during the third trimester, when fe...
A COMPARISON OF DIFFERENT AI AND ML ALGORITHMS FOR ANALYSING SATELLITE IMAGERY AND OTHER REMOTESENSING DATA TO MONITOR MINING ACTIVITIES, INCLUDING THE POTENTIAL FOR INTEGRATING THESE THECHNOLOGIES WITH GMES SYSTEMS.
Monitoring mining activities is crucial for environmental sustainability and resource management. This study explores the application of AI and ML algorithms in analyzing satellite imagery and remote sensing data to enha...
HISTORY OF THE DEVELOPMENT OF EPIDEMIOLOGY AS A GENERAL MEDICAL SCIENCE
Abstract The article provides brief information on the history of the epidemiology of infectious and non-infectious diseases and shares the achievements and experience of studying these diseases in recent years. Epide...